Normative reference and Terms & conditions

P

pikeman

#1
I am unclear about the purpose of Normative reference and Terms and definitions. Can someone explain and suggest suitable wording/references for our quality manual.

------------------
 
Elsmar Forum Sponsor
D

Dan Larsen

#2
I fully agree. The first three sections contain no "shalls", therefore don't have to be distinctly addressed. In effect, these are introductory sections to the standard. The meat is in 4 through 8.
 
D

Dan Larsen

#3
By the way...in answer to the original question (I think): (1)The normative reference essentially says that if another document is referenced in the standard, the most current applies unless the reference is dated; (2)This section does nothing more than define the terms "supplier", "organization", and "customer" as they're used in the standard.
 
E

energy

#4
I may be mistaken, but my thought is that you do NOT have to reference 1.,2., or 3. in your QPM. You begin at 4. in the standard.
 
P

pikeman

#5
The point is that, rightly or wrongly, this information is part of the introduction to our Quality Manual. It is also in the standard and therefore, being keen, we wanted to understand the relevence and meaning.

We asked a consultant and a well known UKAS registered Certification Company and got two different answers. The Certification Company e-mailed us to say that they had got it wrong (they originally said it was connected to other industry legislative standards).

We now believe that normative reference is: ISO 9000:2000, Quality Management Systems - Fundamentals and Vocabulary.

Terms and definitions, as mentioned earlier, supplier - organization - customer.

Understanding the above helps boost confidence. In the past it has been too easy to skip over grey areas pretending that we understand. Our experience with the two parties we talked to about this was an eyeopener and leaves us wondering if there are other areas of the standard that are 'nodded at' in the passing.

[This message has been edited by pikeman (edited 03 March 2001).]
 
Thread starter Similar threads Forum Replies Date
T Definition What does the term "Normative reference" mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
Stuart Andrews Normative reference. Has it changed? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Normative References for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
L Particular, Normative and Collateral - IEC EN 60601 Definitions of IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
T Should I include Normative References in our Systems Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M ISO 14971 becomes mandatory in Brazil - ANVISA Normative Instruction 13/2009 ISO 14971 - Medical Device Risk Management 23
S Normative References and 4.3.2 Legal Requirements ISO 14001:2015 Specific Discussions 7
I Hold Time studies for Primary Reference standards Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
E 510k reference devices US Food and Drug Administration (FDA) 4
G Seeking reference guides/ documentation /tips on verification best practices Other Medical Device Related Standards 6
B Qualifying a reference analyzer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
E MSA Reference Manual 2nd Edition Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
M Reference to an archived template in multiple SOPs ISO 13485:2016 - Medical Device Quality Management Systems 2
R Statistical Methods for comparing test and reference product equivalence for quality attributes US Food and Drug Administration (FDA) 3
K COPLANARITY: Composite profile tolerance on multiple surfaces- what does" lower dimensional reference frame tolerance" control? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
C KAPPA index Reference Value for Visual inspection IATF 16949 - Automotive Quality Systems Standard 1
G GD&T applied to reference dimension. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
C IVD Metrological traceability without a reference measurement procedure General Measurement Device and Calibration Topics 11
M Reference part calibration or verification General Measurement Device and Calibration Topics 12
G Need journal and reference of abnormal bar chart SPC Statistical Analysis Tools, Techniques and SPC 4
W Do Reference materials for IATF need to be 17025? IATF 16949 - Automotive Quality Systems Standard 15
W What is okay to use as a reference material for ISO 17025? ISO 17025 related Discussions 4
M SOPs - Reference Documents Section Document Control Systems, Procedures, Forms and Templates 4
B Reference to IEC 60950-1 in Amendment 2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
Dazza 9001, 14001 and 45001 mandatory documents and records cross reference matrix Process Maps, Process Mapping and Turtle Diagrams 1
T CSE 5.01 reference on drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
J Sample size for creating a data base as a reference to a tested variable Other Medical Device and Orthopedic Related Topics 6
R ASQ reference material clarification - Spiral bound materials allowed in ASQ Exam? Professional Certifications and Degrees 1
D Good Acceptance Activity/Inspection flowchart for reference - Wanted Please Process Maps, Process Mapping and Turtle Diagrams 2
G Customer complaint over a Reference Dimension Manufacturing and Related Processes 9
G Measure 3 times, for calibration report? Customer Owned Reference Standard General Measurement Device and Calibration Topics 4
I Data Backup Plan - Document Reference ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q How to efficiently and compliantly reference external standards/regulations Other Medical Device Related Standards 2
S Lot assignment for secondary reference standard - Pharmaceuticals Manufacturing and Related Processes 0
V Inspection with 3D Scanning - Reference Data Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
E Ethylene Oxide Sterilization Validation-Reference Load Other Medical Device Related Standards 8
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
C Do Calibration Reference Standards require an MSA study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
M Quality Policy - Standards and reference numbers ISO 13485:2016 - Medical Device Quality Management Systems 14
M Reference to IATF 16949 clause 8.4.3 in clause 8.3.4.4, Is it right? IATF 16949 - Automotive Quality Systems Standard 1
S Reference calibration tools (traceable to NIST) that are not used in production ISO 13485:2016 - Medical Device Quality Management Systems 4
S Contract Manufacturer Question - Whether or not the reference to the ex-CMO ISO 13485:2016 - Medical Device Quality Management Systems 6
B Need to convert Reference Only M&TE to a calibration schedule General Measurement Device and Calibration Topics 3
M Looking for Cross reference of AS9100:2016 to ISO13485 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
E Print only has Reference Dimensions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5

Similar threads

Top Bottom